The packaging of medical devices, and in particular surgical instruments, is subject to a number of competing considerations. First, the packaging must properly surround an protect the device from damage and protect any personnel handling the package from injury. Second, the packaging materials must be chosen to accommodate any sterilization processes required for the device and retain its sterility. This requirement also affects which instruments are packaged together, a consideration also driven by the procedure being performed. It is currently standard practice to try to package instruments and related equipment together into a procedure kit where feasible. Finally, and possibly most importantly, in use the packaging must be unobtrusive and present the packaged items conveniently and quickly. Of course, medical device packages are also subject to more conventional considerations such as the cost of materials, the cost and complexity of tooling to make the package, ease of package assembly, and ease of manufacture and shipping both the empty package and the packaged components. The increasingly competitive economic environment exacerbates these sometimes competing considerations; efficacy must be achieved while costs are maintained at a minimum.
The problems and considerations described above are readily apparent when considering the packaging of devices for endoscopic surgery. The general background of endoscopic surgery is known and is described in co-pending U.S. Patent application Ser. No. 947,662, entitled "Endoscopic Suturing Device," filed on Sep. 18, 1992, now U.S. Pat. No. 5,234,445, which is assigned to the assignee of the present invention and incorporated herein by reference. A package for the type of suture loop and cannula disclosed therein is shown in U.S. Pat. No. 5,226,535. As explained therein, it is desirable to package the suture loop and cannula so that the loop is held in an open position and so that they can be readily removed from the package. It is also explained that these types of instruments are typically placed in a plastic overwrap envelope prior to sterilization, and that the package must therefore protect the overwrap from puncture.
Currently, it is recommended practice that devices such as the suture loop and cannula described in these applications are inserted into the patient using an introducer. In order to ensure that the appropriate size introducer is readily available, it is therefore desirable to package the introducer together with the suture loop cannula. The constraints mentioned above dictate that any package for retaining the introducer must be able to be sterilized together with he suture loop and cannula, and should therefore fit within and not interfere with the plastic overwrap. Moreover, it would be desirable to produce such a package without having to redesign the package for the suture loop and cannula, which is typically sealed within a foil pouch.
Accordingly, it is generally an object of the present invention to provide packaging that will permit components or instruments to be packaged together. It is a further object of the present invention to provide packaging designs that are easily adapted for use with the packaging of existing components. It is another object of the present invention that such packages permit ready and efficient access to the component or instrument that they retain. It is more specifically an object of the present invention to disclose a foldable package for retaining an introducer to a package containing a suture loop and cannula.